Source: FDA, National Drug Code (US) Revision Year: 2021
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Select patients for treatment with TEPMETKO based on the presence of MET exon 14 skipping alterations in plasma or tumor specimens. Testing for the presence of MET exon 14 skipping alterations in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. If an alteration is not detected in a plasma specimen, re-evaluate the feasibility of biopsy for tumor tissue testing. An FDA-approved test for detection of MET exon 14 skipping alterations in NSCLC for selecting patients for treatment with TEPMETKO is not available.
The recommended dosage of TEPMETKO is 450 mg orally once daily with food [see Clinical Pharmacology (12.3)] until disease progression or unacceptable toxicity.
Instruct patients to take their dose of TEPMETKO at approximately the same time every day and to swallow tablets whole. Do not chew, crush or split tablets.
Advise patients not to make up a missed dose within 8 hours of the next scheduled dose.
If vomiting occurs after taking a dose of TEPMETKO, advise patients to take the next dose at the scheduled time.
The recommended dose reduction of TEPMETKO for the management of adverse reactions is 225 mg orally once daily.
Permanently discontinue TEPMETKO in patients who are unable to tolerate 225 mg orally once daily.
The recommended dosage modifications of TEPMETKO for adverse reactions are provided in Table 1.
Table 1. Recommended TEPMETKO Dosage Modifications for Adverse Reactions:
| Adverse Reaction | Severity | Dose Modification |
|---|---|---|
| Interstitial Lung Disease (ILD) /Pneumonitis [see Warnings and Precautions (5.1)] | Any grade | Withhold TEPMETKO if ILD is suspected. Permanently discontinue TEPMETKO if ILD is confirmed. |
| Increased ALT and/or AST without increased total bilirubin [see Warnings and Precautions (5.2)] | Grade 3 | Withhold TEPMETKO until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume TEPMETKO at the same dose; otherwise resume TEPMETKO at a reduced dose. |
| Grade 4 | Permanently discontinue TEPMETKO. | |
| Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis [see Warnings and Precautions (5.2)] | ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN | Permanently discontinue TEPMETKO. |
| Increased total bilirubin without concurrent increased ALT and/or AST [see Warnings and Precautions (5.2)] | Grade 3 | Withhold TEPMETKO until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TEPMETKO at a reduced dose; otherwise permanently discontinue. |
| Grade 4 | Permanently discontinue TEPMETKO. | |
| Other adverse reactions [see Adverse Reactions (6.1)] | Grade 2 | Maintain dose level. If intolerable, consider withholding TEPMETKO until resolved, then resume TEPMETKO at a reduced dose. |
| Grade 3 | Withhold TEPMETKO until resolved, then resume TEPMETKO at a reduced dose. | |
| Grade 4 | Permanently discontinue TEPMETKO. |
Store TEPMETKO at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP-NF Controlled Room Temperature]. Store in original package.
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